Providing a continuity of care across multiple care settings

ABSTRACT

The present disclosure provides methods of providing a continuity of care for a patient during transfer between care settings. The method includes the steps of deciding to transfer a patient from a first care setting to a second care setting, performing a first assessment of the patient in the first care setting, preparing a transfer record of the assessment, and transferring the transfer record with the patient to the second care setting.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims benefit of U.S. Provisional Application No.62/587,337, which was filed Nov. 16, 2017 and U.S. ProvisionalApplication No. 62/693,810, which was filed Jul. 3, 2018. The entirecontent of these applications is incorporated herein by reference.

FIELD

The present disclosure provides methods of transferring and handlingpatient information, in particular information related to the risk ofdeveloping a pressure ulcer, to improve care when a patient receivescare in multiple settings.

BACKGROUND

The skin is the largest organ in the human body. It is readily exposedto different kinds of damages and injuries. When the skin and itssurrounding tissues are unable to redistribute external pressure andmechanical forces, ulcers may be formed. Prolonged continuous exposureto even modest pressure, such as the pressure created by the body weightof a supine patient on their posterior skin surfaces, may lead to apressure ulcer. In the presence of other damage, such as the neuropathyand peripheral tissue weakening that can be induced by diabetes, evenperiodic exposure to moderate levels of pressure and stress may lead toan ulcer, for example a foot ulcer.

Pressure ulcers are developed by approximately 2.5 million people a yearin the United States and an equivalent number in the European Union. Inlong-term and critical-care settings, up to 25% of elderly and immobilepatients develop pressure ulcers. Approximately 60,000 U.S. patients dieper year due to infection and other complications from pressure ulcers.

Detecting tissue damage before the skin breaks and intervening with theappropriate therapy to avoid further deterioration of the underlyingtissue is desirable not only for the patient but society. The averagecost of treating pressure-induced damage at the earliest visible sign (aStage 1 ulcer) is only $2,000 but this rises to $129,000 when the ulceris deep enough to expose muscle or bone (a Stage 4 ulcer.) Currently,patients normally receive universal prevention of pressure ulcers,meaning that the prevention does not target to any particular anatomicalsites. Patients only receive a targeted, localized, treatment of ulcerafter the pressure ulcer is developed to the point that it can beidentified by a visual assessment. The current standard to detectpressure ulcers is by visual inspection, which is subjective,unreliable, untimely, and lacks specificity. Therefore, even when apatient is experiencing inflammation of the skin, a precursor of ulcerdevelopment, he or she would not be receiving a targeted, localizedtreatment for the developing ulcer. Instead, the inflammation wouldcontinue to develop into a full-blown ulcer.

In current practice, an independent assessment of a patient's risk ofdeveloping a pressure ulcer is performed upon arrive in a care setting.This lack of knowledge from the prior care setting may diminish thequality of care received at the new care setting.

SUMMARY

In one aspect, the present disclosure provides for, and includes, amethod of identifying and providing an appropriate level of pressureulcer care to a patient based on a plurality of Sub-Epidermal Moisture(SEM) measurements. In an aspect, a patient is provided withincreasingly effective pressure ulcer interventions based on changes inSEM measurements. In an aspect, a patient is given less intensivepressure ulcer interventions based on changes in SEM measurements.

A method of providing a continuity of care for a patient during transferbetween care settings, the method comprising the steps of: deciding totransfer a patient from a first care setting to a second care setting,performing a first assessment of the patient in the first care setting,preparing a transfer record of the assessment, and transferring thetransfer record with the patient to the second care setting.

In an aspect, the present disclosure provides for, and includes, amethod of identifying and treating a patient in need of pressure ulcertreatment, the method comprising the steps of: evaluating a patient fora risk of pressure ulcer in a patient upon admission to a care facility,where the evaluating step comprises making a first plurality ofSub-Epidermal Moisture (SEM) measurements in the patient, calculating afirst delta value from a portion of the first plurality of SEMmeasurements, determining whether the first delta value exceeds a firstthreshold, administering a first intervention of level-0 if the firstdelta value does not exceed the first threshold, and administering afirst intervention of level-N if the first delta value exceeds the firstthreshold, where N is an integer and N has a value of 1 or greater. In afurther aspect, the present disclosure provides for, and includes,making a second plurality of SEM measurements in the patient at a firstpre-determined frequency corresponding to the administered interventionlevel, calculating a second delta value from a portion of the secondplurality of SEM measurements, determining whether the second deltavalue exceeds a second threshold, continuing to administer the firstintervention if the second delta value does not exceed the secondthreshold, continuing to make a plurality of SEM measurements at thefirst pre-determined frequency if the second delta value does not exceedthe second threshold, administering a second intervention of level-M ifthe second delta value exceeds the second threshold, where M is aninteger and M is greater than N, and making a plurality of SEMmeasurements at a second pre-determined frequency corresponding tolevel-M if the second delta value exceeds the second threshold. In yet afurther aspect, the present disclosure provides for, and includes,determining whether the second delta value is less than a thirdthreshold, administering a level-(N−1) intervention if the second deltavalue is less than the third threshold and if the first intervention isnot of level-0, and making a plurality of SEM measurements at apre-determined frequency corresponding to level-(N−1) if the seconddelta value is less than the third threshold.

In one aspect, the present disclosure provides for, and includes, amethod of slowing the progression of pressure ulcer development in apatient in need thereof, the method comprising the steps of: identifyinga current intervention of level-K received by the patient, making aplurality of Sub-Epidermal Moisture (SEM) measurements in the patient,calculating a delta value from a portion of the plurality of SEMmeasurements, determining whether the delta value exceeds a firstthreshold, continuing to administer the current intervention if thedelta value does not exceed the first threshold, continuing to make aplurality of SEM measurements at a pre-determined frequencycorresponding to level-K if the delta value does not exceed the firstthreshold, administering a new intervention of level-N if the deltavalue exceeds the first threshold, where N has a value greater than K,and making a plurality of SEM measurements at a pre-determined frequencycorresponding to level-N if the delta value exceeds the first threshold.In a further aspect, the present disclosure provides for, and includes,determining whether the delta value is less than a second threshold,administering a level-L intervention if the delta value is less than thesecond threshold, where L has a non-negative value less than K, andmaking a plurality of SEM measurements at a pre-determined frequencycorresponding to level-L if the delta value is less than the secondthreshold.

In an aspect, the present disclosure provides for, and includes, amethod of stratifying groups of patients in a care facility based onpressure ulcer risk, the method comprising the steps of: making aplurality of Sub-Epidermal Moisture (SEM) measurements in each of thepatients, calculating a delta value from a portion of the plurality ofSEM measurements for each of the patients, determining whether eachdelta value exceeds any values in a set of threshold valuescorresponding to N care levels and assigning a care level to each of thepatients, rearranging the group of patients based on each of thepatient's assigned care levels.

In one aspect, the present disclosure provides for, and includes, amethod of reducing incidence of pressure ulcer in patients admitted to acare facility, the method comprising the steps of: evaluating a patientfor a risk of pressure ulcer upon admission to the care facility, wherethe evaluating step comprises making a first plurality of Sub-EpidermalMoisture (SEM) measurements in the patient, calculating a first deltavalue from a portion of the first plurality of SEM measurements,determining whether the first delta value exceeds a first threshold,administering a first intervention of level-0 if the first delta valuedoes not exceed the first threshold, and administering a & interventionof level-N if the first delta value exceeds the first threshold, where Nis an integer and N has a value of 1 or greater.

In an aspect, the present disclosure provides for, and includes, amethod of identifying and treating a patient in need of application of abarrier cream to the patient's heel, the method comprising the steps of:making a plurality of Sub-Epidermal Moisture (SEM) measurements at thepatient's heel, calculating a delta value from a portion of theplurality of SEM measurements, determining whether the delta valueexceeds a threshold corresponding to level N, where N is greater than orequal to 2, administering a barrier cream to the patient's heel if thedelta value exceeds the threshold, and making a plurality of SEMmeasurements every two hours if the delta value exceeds the threshold.

In one aspect, the present disclosure provides for, and includes, amethod of identifying and treating a patient in need of application of aneuro-muscular stimulation to the patient's heel, the method comprisingthe steps of: making a plurality of Sub-Epidermal Moisture (SEM)measurements at the patient's heel, calculating a delta value from aportion of the plurality of SEM measurements, determining whether thedelta value exceeds a threshold corresponding to level N, where N isgreater than or equal to 2, administering a neuro-muscular stimulationto the patient's heel if the delta value exceeds the threshold, andmaking a plurality of SEM measurements every hour if the delta valueexceeds the threshold.

In an aspect, the present disclosure provides for, and includes, amethod of identifying and treating a patient in need of application of atopical cream to the patient's heel, the method comprising the steps of:making a plurality of Sub-Epidermal Moisture (SEM) measurements at thepatient's heel, calculating a delta value from a portion of theplurality of SEM measurements, determining whether the delta valueexceeds a threshold corresponding to level N, where N is greater than orequal to 2, administering a topical cream to the patient's heel if thedelta value exceeds the threshold, and making a plurality of SEMmeasurements every half an hour if the delta value exceeds thethreshold.

In one aspect, the present disclosure provides for, and includes, amethod of identifying and treating a patient in need of application of abarrier cream to the patient's sacrum, the method comprising the stepsof: making a plurality of Sub-Epidermal Moisture (SEM) measurements atthe patient's sacrum, calculating a delta value from a portion of theplurality of SEM measurements, determining whether the delta valueexceeds a threshold corresponding to level N, where N is greater than orequal to 2, administering a barrier cream to the patient's sacrum if thedelta value exceeds the threshold, and making a plurality of SEMmeasurements every six hours if the delta value exceeds the threshold.

In an aspect, the present disclosure provides for, and includes, amethod of identifying and treating a patient in need of application of aneuro-muscular stimulation to the patient's sacrum, the methodcomprising the steps of: making a plurality of Sub-Epidermal Moisture(SEM) measurements at the patient's sacrum, calculating a delta valuefrom a portion of the plurality of SEM measurements, determining whetherthe delta value exceeds a threshold corresponding to level N, where N isgreater than or equal to 2, administering a neuro-muscular stimulationto the patient's sacrum if the delta value exceeds the threshold, andmaking a plurality of SEM measurements every four hours if the deltavalue exceeds the threshold.

In one aspect, the present disclosure provides for, and includes, amethod of identifying and treating a patient in need of application of atopical cream to the patient's sacrum, the method comprising the stepsof: making a plurality of Sub-Epidermal Moisture (SEM) measurements atthe patient's sacrum, calculating a delta value from a portion of theplurality of SEM measurements, determining whether the delta valueexceeds a threshold corresponding to level N, where N is greater than orequal to 2, administering a topical cream to the patient's sacrum if thedelta value exceeds the threshold, and making a plurality of SEMmeasurements every two hours if the delta value exceeds the threshold.

BRIEF DESCRIPTION OF THE DRAWINGS

The patent or application file contains at least one drawing executed incolor. Copies of this patent or patent application publication withcolor drawing(s) will be provided by the Office upon request and paymentof the necessary fee.

Aspects of the disclosure are herein described, by way of example only,with reference to the accompanying drawings. With specific reference nowto the drawings in detail, it is stressed that the particulars shown areby way of example and are for purposes of illustrative discussion ofaspects of the disclosure. In this regard, the description and thedrawings, considered alone and together, make apparent to those skilledin the art how aspects of the disclosure may be practiced.

FIG. 1 depicts an example of an overall process for selecting a pressureulcer treatment based on SEM values from admission to a care facilityuntil discharge from the care facility, in accordance with the presentdisclosure.

FIG. 2A is a sample visual assessment of healthy tissue in accordancewith the present disclosure.

FIG. 2B is a plot of the averages of SEM measurements taken at eachlocation at and around a healthy sacrum in accordance with the presentdisclosure.

FIG. 3A is a sample visual assessment of damaged tissue in accordancewith the present disclosure.

FIG. 3B is a plot of the averages of SEM measurements taken at eachlocation at and around a damaged sacrum in accordance with the presentdisclosure.

FIG. 4 is an illustration of a process for selecting a level ofintervention and monitoring based on the amount by which a delta valuederived from SEM measurements exceeds a threshold value in accordancewith the present disclosure.

FIG. 5 is an example of a workflow guidance matrix where the currentlevel of intervention and the new delta value are used to select the newlevel of intervention in accordance with the present disclosure.

FIGS. 6A, 6B, and 6C depict an example progression over time of a deltavalue for a single patient at a single location where a pressure ulcerdevelops in accordance with the present disclosure.

FIG. 6D is an example plot of a delta value change over time for asingle patient at a single location where a pressure ulcer develops inaccordance with the present disclosure.

FIGS. 7A and 7B are examples of methods of mapping areas of tissuedamage in accordance with the present disclosure.

FIG. 8A is an example of a currently recommended treatment decisionpathway for preventing pressure ulcers in hospital patients using acombination of risk assessment and visual assessment.

FIG. 8B is an example of a current augmented treatment decision pathwayfor preventing pressure ulcers as currently implemented at some healthcare facilities.

FIG. 9 is an example flowchart of how a SEM Scanner may be used in astand-alone process to prevent pressure ulcers, in accordance with thepresent disclosure.

FIG. 10 is an example flowchart of how a SEM Scanner may be used as anadjunct to further improve the augmented treatment decision pathway ofFIG. 8B, in accordance with the present disclosure.

FIG. 11 illustrates the concept of providing a continuity of care acrossmultiple care settings, in accordance with the present disclosure.

DETAILED DESCRIPTION

This description is not intended to be a detailed catalog of all thedifferent ways in which the disclosure may be implemented, or all thefeatures that may be added to the instant disclosure. For example,features illustrated with respect to one embodiment may be incorporatedinto other embodiments, and features illustrated with respect to aparticular embodiment may be deleted from that embodiment. Thus, thedisclosure contemplates that in some embodiments of the disclosure, anyfeature or combination of features set forth herein can be excluded oromitted. In addition, numerous variations and additions to the variousembodiments suggested herein will be apparent to those skilled in theart in light of the instant disclosure, which do not depart from theinstant disclosure. In other instances, well-known structures,interfaces, and processes have not been shown in detail in order not tounnecessarily obscure the invention. It is intended that no part of thisspecification be construed to effect a disavowal of any part of the fullscope of the invention. Hence, the following descriptions are intendedto illustrate some particular embodiments of the disclosure, and not toexhaustively specify all permutations, combinations and variationsthereof.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosure belongs. The terminology used in thedescription of the disclosure herein is for the purpose of describingparticular aspects or embodiments only and is not intended to belimiting of the disclosure.

All publications, patent applications, patents and other referencescited herein are incorporated by reference in their entireties for theteachings relevant to the sentence and/or paragraph in which thereference is presented. References to techniques employed herein areintended to refer to the techniques as commonly understood in the art,including variations on those techniques or substitutions of equivalenttechniques that would be apparent to one of skill in the art.

U.S. patent application Ser. No. 14/827,375 (“the '375 application”)discloses an apparatus that uses radio frequency (RF) energy to measurethe sub-epidermal capacitance using a bipolar sensor, where thesub-epidermal capacitance corresponds to the moisture content of thetarget region of skin of a patient. The '375 application also disclosesan array of these bipolar sensors of various sizes.

U.S. patent application Ser. No. 15/134,110 discloses an apparatus formeasuring sub-epidermal moisture (SEM) similar to the device shown inFIG. 3, where the device emits and receives an RF signal at a frequencyof 32 kHz through a single coaxial sensor and generates a bioimpedancesignal, then converts this signal to a SEM value.

Both U.S. patent application Ser. Nos. 14/827,375 and 15/134,110 areincorporated herein by reference in their entireties. However, the SEMvalues of this application may be measured by any similar or equivalentdevices or techniques that would be apparent to one of skill in the art.For example, a device measuring the SEM values of this application maybe a wired device, a wireless device, or a system comprising variouscomponents in communication with each other.

Unless the context indicates otherwise, it is specifically intended thatthe various features of the disclosure described herein can be used inany combination. Moreover, the present disclosure also contemplates thatin some embodiments of the disclosure, any feature or combination offeatures set forth herein can be excluded or omitted.

The methods disclosed herein include and comprise one or more steps oractions for achieving the described method. The method steps and/oractions may be interchanged with one another without departing from thescope of the present disclosure. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modifiedwithout departing from the scope of the present disclosure.

As used in the description of the disclosure and the appended claims,the singular forms “a,” “an,” and “the” are intended to include theplural forms as well, unless the context clearly indicates otherwise.

As used herein, “and/or” refers to and encompasses any and all possiblecombinations of one or more of the associated listed items, as well asthe lack of combinations when interpreted in the alternative (“or”).

The terms “about” and “approximately” as used herein when referring to ameasurable value such as a length, a frequency, or a SEM value and thelike, is meant to encompass variations of ±20%, ±10%, ±5%, ±1%, ±0.5%,or even ±0.1% of the specified amount.

As used herein, phrases such as “between X and Y” and “between about Xand Y” should be interpreted to include X and Y. As used herein, phrasessuch as “between about X and Y” mean “between about X and about Y” andphrases such as “from about X to Y” mean “from about X to about Y.”

As used herein, the term “sub-epidermal moisture” or “SEM” refers to theincrease in tissue fluid and local edema caused by vascular leakinessand other changes that modify the underlying structure of the damagedtissue in the presence of continued pressure on tissue, apoptosis,necrosis, and the inflammatory process.

As used herein, a “patient” may be a human or animal subject.

As used herein, “delta” refers to a calculated difference between twoSEM values.

As used herein, the variables “K,” “L,” “M,” and “N” are non-negativeintegers.

FIG. 1 depicts an overall process 100 for selecting a pressure ulcertreatment based on SEM values produced from SEM measurements made usingan SEM scanner in accordance with this disclosure, from admission to acare facility until discharge from the care facility. In an aspect, acare facility is selected from the group consisting of a hospital, anassisted living facility, a residential care facility, a nursing home, along-term care facility, a continuing care community, and an independentliving community. In an aspect, a care facility may be a home or otherresidence of the patient, whereupon the “admit” step 102 will be a firstevaluation of a patient at their home by a nurse or other caregiver. Inone aspect, the schedule of interventions and evaluation intervals usedin a home setting may be different than the corresponding interventionsand intervals used at a hospital.

In an aspect, in process 100, a newly admitted patient receives anintake evaluation in step 104 that includes one or more of a visualexamination of a portion of the patient's skin, completion of at least aportion of a risk assessment protocol that evaluates one or more ofnutrition, mobility, physical activity, physical strength, and abilityto communicate, and SEM measurements made in one or more locations onthe patient's skin. In an aspect, the SEM measurements may includemaking a plurality of SEM measurements at a single “location” on thepatient's skin. In one aspect, “location” is considered as an arearather than a single point such that SEM measurements may be made atspatially separated points within the location. For example, a “heel”location includes the medial, lateral, and posterior surfaces around theheel as well as the posterior portion of the sole of that foot.

In one aspect, once the evaluation step is complete, a determination ismade in step 106 as to whether the patient is “deviated,” i.e., whetherthe combination of the results of the various elements of the evaluationindicate that the patient has, or is at risk of developing, tissuedamage that could lead to a pressure ulcer. Each element of theevaluation may have an individual criterion for level of risk, forexample a scoring system with threshold value that indicates anunacceptable risk. In an aspect, there is a protocol to combine thecriteria to generate a composite parameter that can be used to select alevel of intervention.

In an aspect, if the patient is determined to be at an acceptable levelof risk, the process branches to step 108 which implements the lowestlevel of intervention, designated herein as “level-zero” or “level-0.”Progressing through steps 110 and 112, the patient will be re-assessedusing at least the SEM measurement protocol in step 114 at a frequency,or conversely a time interval, associated with level-0. The process 100then loops back to step 106 to evaluate the results of the SEMmeasurements made in step 114.

In one aspect, if the patient is determined in step 106 to be deviated,then the process branches to step 122, which implements a higher levelof intervention. In an aspect, there is a defined hierarchy ofintervention levels, with each level implementing a more effectiveintervention than the next-lower level. In an aspect, each level alsohas a defined monitoring interval or frequency indicating how often aset of SEM measurements should be made, where higher levels willgenerally have shorter intervals. In this example, the process has beendefined by the hospital, or other administering organization, to step upone level to a level-1 intervention at this point. In another aspect,step 122 may implement a level-2 or higher level of intervention. Theprocess now enters a new loop starting at step 130 where the patientwill now be monitored at a level-N frequency where N is in the range of1 to n, n being the highest defined level of intervention andmonitoring.

In an aspect, at step 134, the patient's history is evaluated todetermine whether their condition is improving. If the patient'scondition is improving, for example as evidenced by a decreasing deltavalue, then the process branches to step 142. In this example, step 142continues to implement the current level of intervention and the processloops through step 140 to steps 130-132-134-142-140 until the deltavalue drops below the threshold. In an aspect, the level of interventionmay be reduced in step 142 based on the magnitude of the delta value asthe delta value trends downward.

In one aspect, if the patient does not show improvement in step 134, theprocess branches to an increase in the level of intervention in step 138provided that the skin is not broken, i.e., an open ulcer has notdeveloped, in step 136. If an open ulcer has developed, the SEM scanningwill now be performed around the periphery of the open wound in step 144to map inflammation or other precursor indication of the ulcerspreading. The ulcer itself is treated in step 148 and this secondaryloop 144-146-148-150 continues until the wound closes, whereupon theprocess returns to step 130.

In an aspect, at any time in process 100, discharge of the patientbranches to step 118, where the condition of the patient upon dischargeor transfer is documented. In an aspect, step 118 comprises a final setof SEM measurements at one of more locations on the patient's body. Inan aspect, these locations include areas that were not receiving anintervention and were not previously identified as at risk. In anaspect, this information is provided to the receiving caregiver. Thepatient is then discharged or transferred in step 120.

In an aspect, the present disclosure provides for, and includes, amethod of identifying and treating a patient in need of pressure ulcertreatment, the method comprising the steps of: evaluating a patient fora risk of pressure ulcer in a patient upon admission to a care facility,where the evaluating step comprises making a first plurality ofSub-Epidermal Moisture (SEM) measurements in the patient, calculating afirst delta value from a portion of the first plurality of SEMmeasurements, determining whether the first delta value exceeds a firstthreshold, administering a first intervention of level-0 if the firstdelta value does not exceed the first threshold, and administering afirst intervention of level-N if the first delta value exceeds the firstthreshold, where N is an integer and N has a value of 1 or greater.

In one aspect, a first plurality of SEM measurements is taken at andaround one or more anatomical sites selected from the group consistingof a sternum, a sacrum, a heel, a scapula, an elbow, an ear, and otherfleshy tissues of a patient. In an aspect, a first plurality of SEMmeasurements is separated into sub-groups for analysis based on thegeneral location at which a measurement is taken. In one aspect, a firstplurality of SEM measurements is taken at locations located on one ormore concentric circles centered around an anatomical site. In anaspect, a first plurality of SEM measurements is taken at locationslocated on a straight line at approximately equidistance from ananatomical site.

In one aspect, a first delta value is determined by the differencebetween the maximum SEM value and the minimum SEM value from the firstplurality of SEM measurements collected. In an aspect, a first deltavalue is determined by the difference between the maximum SEM average ofmeasurements taken at one location and the minimum SEM average ofmeasurements taken at a second location. In one aspect, a first deltavalue is determined for a portion of a first plurality of SEMmeasurements made up of a sub-group as defined by location taken. In anaspect, an average SEM value at a location is obtained from two, three,four, five, six, seven, eight, nine, ten, or more than ten SEM valuesmeasured at that location. In one aspect, a first delta value isdetermined by the difference between SEM values derived frommeasurements taken at two bisymmetric locations with respect to acenterline.

In an aspect, a delta value may be calculated from a plurality of SEMmeasurements made at a certain location, or in close proximity around aspecific location, in a plurality of methods. In an aspect, a pluralityof SEM measurements are made in a pre-determined pattern on the skin andthe delta value is calculated by subtracting the SEM value associatedwith a pre-determined position within the pattern from the largest SEMvalue made at the other positions in the pattern. In an aspect, aplurality of SEM measurements are made in a pre-determined pattern onthe skin and the delta value is calculated by identifying the SEM valueassociated with a pre-determined position within the pattern andsubtracting the largest SEM value made at the other positions in thepattern. In an aspect, an average SEM value may be calculated from aportion of a set of SEM values generated by a plurality of SEMmeasurements at a single location and a delta value calculated as thelargest difference between the average and a single SEM value of thesame set. In an aspect, a delta value may be calculated as a ratio ofthe largest SEM value to the smallest SEM value within a set of SEMvalues.

In an aspect, a first threshold may be about 0.3, 0.35, 0.4, 0.45, 0.5,0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3,1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7,2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1,4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5,5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9,7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one aspect, a first threshold mayrange from 0.1 to 8.0, such as from 0.1 to 1.0, from 1.1 to 2.0, from2.1 to 3.0, from 3.1 to 4.0, from 4.1 to 5.0, from 5.1 to 6.0, from 6.1to 7.0, from 7.1 to 8.0, from 0.1 to 7.5, from 0.5 to 8.0, from 1.0 to7.0, from 1.5 to 6.5, from 2.0 to 6.0, from 3.0 to 5.5, from 3.5 to 5.0,or from 4.0 to 4.5. In an aspect, a first threshold can be scaled by afactor or a multiple based on the values provided herein. It will beunderstood that a threshold is not limited by design, but rather, one ofordinary skill in the art would be capable of choosing a predeterminedvalue based on a given unit of SEM. In one aspect, thresholds of thepresent disclosure are varied according to the specific portion of apatient's body on which measurements are being made, or one or morecharacteristics of the patient such as age, height, weight, familyhistory, ethnic group, and other physical characteristics or medicalconditions.

In an aspect, N ranges from 1 to 50, such as from 1 to 2, from 1 to 3,from 1 to 4, from 1 to 5, from 1 to 6, from 1 to 7, from 1 to 8, from 1to 9, from 1 to 10, from 1 to 15, from 1 to 20, from 1 to 25, from 1 to30, from 1 to 35, from 1 to 40, or from 1 to 45.

In one aspect, N is determined by the amount by which the first deltavalue exceeds the first threshold. In an aspect, the amount by which adelta value exceeds a threshold established for (N+1) is greater thanthe amount by which a delta value exceeds a threshold established for N.In one aspect, the amount by which a delta value exceeds a thresholdestablished for (N−1) is less than the amount by which a delta valueexceeds a threshold established for N.

In an aspect, a level-1 (N=1) intervention is applied to a patienthaving a delta value exceeding the threshold by not more than 100% ofthe threshold value, such as not more than 95%, not more than 90%, notmore than 85%, not more than 80%, not more than 75%, not more than 70%,not more than 65%, not more than 60%, not more than 55%, not more than50%, not more than 45%, not more than 40%, not more than 35%, not morethan 30%, not more than 25%, not more than 20%, not more than 15%, notmore than 10%, or not more than 5% of the threshold value.

In an aspect, a level-2 (N=2) intervention is applied to a patienthaving a delta value exceeding the threshold by not more than 150% ofthe threshold value, such as not more than 145%, not more than 140%, notmore than 135%, not more than 130%, not more than 125%, not more than120%, not more than 115%, not more than 110%, not more than 100%, notmore than 95%, not more than 90%, not more than 85%, not more than 80%,not more than 75%, not more than 70%, not more than 65%, not more than60%, not more than 55%, not more than 50%, not more than 45%, not morethan 40%, not more than 35%, not more than 30%, not more than 25%, notmore than 20%, not more than 15%, not more than 10%, or not more than 5%of the threshold value.

In one aspect, a level-3 (N=3) intervention is applied to a patienthaving a delta value exceeding the threshold by not more than 200% ofthe threshold value, such as not more than 195%, not more than 190%, notmore than 185%, not more than 180%, not more than 175%, not more than170%, not more than 165%, not more than 160%, not more than 155%, notmore than 150%, not more than 145%, not more than 140%, not more than135%, not more than 130%, not more than 125%, not more than 120%, notmore than 115%, not more than 110%, not more than 100%, not more than95%, not more than 90%, not more than 85%, not more than 80%, not morethan 75%, not more than 70%, not more than 65%, not more than 60%, notmore than 55%, not more than 50%, not more than 45%, not more than 40%,not more than 35%, not more than 30%, not more than 25%, not more than20%, not more than 15%, not more than 10%, or not more than 5% of thethreshold value.

In one aspect, a level-4 (N=4) intervention is applied to a patienthaving a delta value exceeding the threshold by not more than 250% ofthe threshold value, such as not more than 245%, not more than 240%, notmore than 235%, not more than 230%, not more than 225%, not more than220%, not more than 215%, not more than 210%, not more than 205%, notmore than 200%, not more than 195%, not more than 190%, not more than185%, not more than 180%, not more than 175%, not more than 170%, notmore than 165%, not more than 160%, not more than 155%, not more than150%, not more than 145%, not more than 140%, not more than 135%, notmore than 130%, not more than 125%, not more than 120%, not more than115%, not more than 110%, not more than 100%, not more than 95%, notmore than 90%, not more than 85%, not more than 80%, not more than 75%,not more than 70%, not more than 65%, not more than 60%, not more than55%, not more than 50%, not more than 45%, not more than 40%, not morethan 35%, not more than 30%, not more than 25%, not more than 20%, notmore than 15%, not more than 10%, or not more than 5% of the thresholdvalue.

In one aspect, a level-5 (N=5) intervention is applied to a patienthaving a delta value exceeding the threshold by not more than 300% ofthe threshold value, such as not more than 295%, not more than 290%, notmore than 285%, not more than 280%, not more than 275%, not more than270%, not more than 265%, not more than 260%, not more than 255%, notmore than 250%, not more than 245%, not more than 240%, not more than235%, not more than 230%, not more than 225%, not more than 220%, notmore than 215%, not more than 210%, not more than 205%, not more than200%, not more than 195%, not more than 190%, not more than 185%, notmore than 180%, not more than 175%, not more than 170%, not more than165%, not more than 160%, not more than 155%, not more than 150%, notmore than 145%, not more than 140%, not more than 135%, not more than130%, not more than 125%, not more than 120%, not more than 115%, notmore than 110%, not more than 100%, not more than 95%, not more than90%, not more than 85%, not more than 80%, not more than 75%, not morethan 70%, not more than 65%, not more than 60%, not more than 55%, notmore than 50%, not more than 45%, not more than 40%, not more than 35%,not more than 30%, not more than 25%, not more than 20%, not more than15%, not more than 10%, or not more than 5% of the threshold value.

In one aspect, a level-6 (N=6) intervention is applied to a patienthaving a delta value exceeding the threshold by not more than 350% ofthe threshold value, such as not more than 345%, not more than 340%, notmore than 335%, not more than 330%, not more than 325%, not more than320%, not more than 315%, not more than 310%, not more than 305%, notmore than 300%, not more than 295%, not more than 290%, not more than285%, not more than 280%, not more than 275%, not more than 270%, notmore than 265%, not more than 260%, not more than 255%, not more than250%, not more than 245%, not more than 240%, not more than 235%, notmore than 230%, not more than 225%, not more than 220%, not more than215%, not more than 210%, not more than 205%, not more than 200%, notmore than 195%, not more than 190%, not more than 185%, not more than180%, not more than 175%, not more than 170%, not more than 165%, notmore than 160%, not more than 155%, not more than 150%, not more than145%, not more than 140%, not more than 135%, not more than 130%, notmore than 125%, not more than 120%, not more than 115%, not more than110%, not more than 100%, not more than 95%, not more than 90%, not morethan 85%, not more than 80%, not more than 75%, not more than 70%, notmore than 65%, not more than 60%, not more than 55%, not more than 50%,not more than 45%, not more than 40%, not more than 35%, not more than30%, not more than 25%, not more than 20%, not more than 15%, not morethan 10%, or not more than 5% of the threshold value.

In one aspect, a level-7 (N=7) intervention is applied to a patienthaving a delta value exceeding the threshold by not more than 400% ofthe threshold value, such as not more than 395%, not more than 390%, notmore than 385%, not more than 380%, not more than 375%, not more than370%, not more than 365%, not more than 360%, not more than 355%, notmore than 350%, not more than 345%, not more than 340%, not more than335%, not more than 330%, not more than 325%, not more than 320%, notmore than 315%, not more than 310%, not more than 305%, not more than300%, not more than 295%, not more than 290%, not more than 285%, notmore than 280%, not more than 275%, not more than 270%, not more than265%, not more than 260%, not more than 255%, not more than 250%, notmore than 245%, not more than 240%, not more than 235%, not more than230%, not more than 225%, not more than 220%, not more than 215%, notmore than 210%, not more than 205%, not more than 200%, not more than195%, not more than 190%, not more than 185%, not more than 180%, notmore than 175%, not more than 170%, not more than 165%, not more than160%, not more than 155%, not more than 150%, not more than 145%, notmore than 140%, not more than 135%, not more than 130%, not more than125%, not more than 120%, not more than 115%, not more than 110%, notmore than 100%, not more than 95%, not more than 90%, not more than 85%,not more than 80%, not more than 75%, not more than 70%, not more than65%, not more than 60%, not more than 55%, not more than 50%, not morethan 45%, not more than 40%, not more than 35%, not more than 30%, notmore than 25%, not more than 20%, not more than 15%, not more than 10%,or not more than 5% of the threshold value.

In one aspect, a level-8 (N=8) intervention is applied to a patienthaving a delta value exceeding the threshold by not more than 450% ofthe threshold value, such as not more than 445%, not more than 440%, notmore than 435%, not more than 430%, not more than 425%, not more than420%, not more than 415%, not more than 410%, not more than 405%, notmore than 400%, not more than 395%, not more than 390%, not more than385%, not more than 380%, not more than 375%, not more than 370%, notmore than 365%, not more than 360%, not more than 355%, not more than350%, not more than 345%, not more than 340%, not more than 335%, notmore than 330%, not more than 325%, not more than 320%, not more than315%, not more than 310%, not more than 305%, not more than 300%, notmore than 295%, not more than 290%, not more than 285%, not more than280%, not more than 275%, not more than 270%, not more than 265%, notmore than 260%, not more than 255%, not more than 250%, not more than245%, not more than 240%, not more than 235%, not more than 230%, notmore than 225%, not more than 220%, not more than 215%, not more than210%, not more than 205%, not more than 200%, not more than 195%, notmore than 190%, not more than 185%, not more than 180%, not more than175%, not more than 170%, not more than 165%, not more than 160%, notmore than 155%, not more than 150%, not more than 145%, not more than140%, not more than 135%, not more than 130%, not more than 125%, notmore than 120%, not more than 115%, not more than 110%, not more than100%, not more than 95%, not more than 90%, not more than 85%, not morethan 80%, not more than 75%, not more than 70%, not more than 65%, notmore than 60%, not more than 55%, not more than 50%, not more than 45%,not more than 40%, not more than 35%, not more than 30%, not more than25%, not more than 20%, not more than 15%, not more than 10%, or notmore than 5% of the threshold value.

In one aspect, a level-9 (N=9) intervention is applied to a patienthaving a delta value exceeding the threshold by not more than 500% ofthe threshold value, such as not more than 495%, not more than 490%, notmore than 485%, not more than 480%, not more than 475%, not more than470%, not more than 465%, not more than 460%, not more than 455%, notmore than 450%, not more than 445%, not more than 440%, not more than435%, not more than 430%, not more than 425%, not more than 420%, notmore than 415%, not more than 410%, not more than 405%, not more than400%, not more than 395%, not more than 390%, not more than 385%, notmore than 380%, not more than 375%, not more than 370%, not more than365%, not more than 360%, not more than 355%, not more than 350%, notmore than 345%, not more than 340%, not more than 335%, not more than330%, not more than 325%, not more than 320%, not more than 315%, notmore than 310%, not more than 305%, not more than 300%, not more than295%, not more than 290%, not more than 285%, not more than 280%, notmore than 275%, not more than 270%, not more than 265%, not more than260%, not more than 255%, not more than 250%, not more than 245%, notmore than 240%, not more than 235%, not more than 230%, not more than225%, not more than 220%, not more than 215%, not more than 210%, notmore than 205%, not more than 200%, not more than 195%, not more than190%, not more than 185%, not more than 180%, not more than 175%, notmore than 170%, not more than 165%, not more than 160%, not more than155%, not more than 150%, not more than 145%, not more than 140%, notmore than 135%, not more than 130%, not more than 125%, not more than120%, not more than 115%, not more than 110%, not more than 100%, notmore than 95%, not more than 90%, not more than 85%, not more than 80%,not more than 75%, not more than 70%, not more than 65%, not more than60%, not more than 55%, not more than 50%, not more than 45%, not morethan 40%, not more than 35%, not more than 30%, not more than 25%, notmore than 20%, not more than 15%, not more than 10%, or not more than 5%of the threshold value.

In one aspect, a level-10 (N=10) intervention is applied to a patienthaving a delta value exceeding the threshold by not more than 550% ofthe threshold value, such as not more than 545%, not more than 540%, notmore than 535%, not more than 530%, not more than 525%, not more than520%, not more than 515%, not more than 510%, not more than 505%, notmore than 500%, not more than 495%, not more than 490%, not more than485%, not more than 480%, not more than 475%, not more than 470%, notmore than 465%, not more than 460%, not more than 455%, not more than450%, not more than 445%, not more than 440%, not more than 435%, notmore than 430%, not more than 425%, not more than 420%, not more than415%, not more than 410%, not more than 405%, not more than 400%, notmore than 395%, not more than 390%, not more than 385%, not more than380%, not more than 375%, not more than 370%, not more than 365%, notmore than 360%, not more than 355%, not more than 350%, not more than345%, not more than 340%, not more than 335%, not more than 330%, notmore than 325%, not more than 320%, not more than 315%, not more than310%, not more than 305%, not more than 300%, not more than 295%, notmore than 290%, not more than 285%, not more than 280%, not more than275%, not more than 270%, not more than 265%, not more than 260%, notmore than 255%, not more than 250%, not more than 245%, not more than240%, not more than 235%, not more than 230%, not more than 225%, notmore than 220%, not more than 215%, not more than 210%, not more than205%, not more than 200%, not more than 195%, not more than 190%, notmore than 185%, not more than 180%, not more than 175%, not more than170%, not more than 165%, not more than 160%, not more than 155%, notmore than 150%, not more than 145%, not more than 140%, not more than135%, not more than 130%, not more than 125%, not more than 120%, notmore than 115%, not more than 110%, not more than 100%, not more than95%, not more than 90%, not more than 85%, not more than 80%, not morethan 75%, not more than 70%, not more than 65%, not more than 60%, notmore than 55%, not more than 50%, not more than 45%, not more than 40%,not more than 35%, not more than 30%, not more than 25%, not more than20%, not more than 15%, not more than 10%, or not more than 5% of thethreshold value.

In one aspect, a level-N intervention is more effective than a level-0intervention. In an aspect, a level-(N+1) intervention is more effectivethan a level-N intervention. In one aspect, a level-(N−1) interventionis less effective than a level-N intervention.

In an aspect, the evaluating step of the present disclosure furthercomprises performing a visual assessment. In one aspect, the visualassessment is performed in accordance with the guidelines of theNational Pressure Ulcer Advisory Panel (NPUAP).

In one aspect, the evaluating step of the present disclosure furthercomprises performing a risk assessment. In an aspect, the riskassessment is performed in accordance with a test selected from thegroup consisting of the Braden Scale, the Gosnell Scale, the NortonScale, and the Waterlow Scale.

In an aspect, the present disclosure further provides for, and includes,making a second plurality of SEM measurements in the patient at a firstpre-determined frequency corresponding to the administered interventionlevel, calculating a second delta value from a portion of the secondplurality of SEM measurements, determining whether the second deltavalue exceeds a second threshold, continuing to administer the firstintervention if the second delta value does not exceed the secondthreshold, continuing to make a plurality of SEM measurements at thefirst pre-determined frequency if the second delta value does not exceedthe second threshold, administering a second intervention of level-M ifthe second delta value exceeds the second threshold, where M is aninteger and M is greater than N, and making a plurality of SEMmeasurements at a second pre-determined frequency corresponding tolevel-M if the second delta value exceeds the second threshold.

In one aspect, a pre-determined frequency is selected from the groupconsisting of at least once every 72 hours, at least once every 48hours, at least once every 24 hours, at least once every 12 hours, atleast once every 8 hours, at least once every 6 hours, at least onceevery 4 hours, at least once every 3 hours, at least once every 2 hours,at least once every hour, and at least once every half an hour.

In one aspect, a second plurality of SEM measurements are taken inaccordance with

In an aspect, a second plurality of SEM measurements are made at thesame locations where a first plurality of SEM measurements were taken.In one aspect, a second plurality of SEM measurements are made at someof the same locations where a first plurality of SEM measurements weretaken. In an aspect, a second plurality of SEM measurements are madenear the locations where a first plurality of SEM measurements weretaken. In one aspect, a second plurality of SEM measurements are made atdifferent locations than where a first plurality of SEM measurementswere taken.

In an aspect, a second delta value is determined by the differencebetween the maximum SEM value and the minimum SEM value from the secondplurality of SEM measurements collected. In one aspect, a second deltavalue is determined by the difference between the maximum SEM average ofmeasurements taken at one location and the minimum SEM average ofmeasurements taken at a second location. In one aspect, a second deltavalue is determined for a portion of a second plurality of SEMmeasurements made up of a sub-group as defined by location taken.

In an aspect, a second threshold may be about 0.3, 0.35, 0.4, 0.45, 0.5,0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3,1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7,2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1,4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5,5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9,7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one aspect, a second threshold mayrange from 0.1 to 8.0, such as from 0.1 to 1.0, from 1.1 to 2.0, from2.1 to 3.0, from 3.1 to 4.0, from 4.1 to 5.0, from 5.1 to 6.0, from 6.1to 7.0, from 7.1 to 8.0, from 0.1 to 7.5, from 0.5 to 8.0, from 1.0 to7.0, from 1.5 to 6.5, from 2.0 to 6.0, from 3.0 to 5.5, from 3.5 to 5.0,or from 4.0 to 4.5. In an aspect, a second threshold can be scaled by afactor or a multiple based on the values provided herein. In one aspect,a second threshold can be the same as a first threshold. In an aspect, asecond threshold can be greater than a first threshold. In one aspect, asecond threshold can be less than a first threshold.

In an aspect, M ranges from 2 to 50, such as from 2 to 3, from 2 to 4,from 2 to 5, from 2 to 6, from 2 to 7, from 2 to 8, from 2 to 9, from 2to 10, from 2 to 15, from 2 to 20, from 2 to 25, from 2 to 30, from 2 to35, from 2 to 40, or from 2 to 45.

In one aspect, M is determined by the amount by which the second deltavalue exceeds the second threshold. In an aspect, the amount by which adelta value exceeds a threshold established for (M+1) is greater thanthe amount by which a delta value exceeds a threshold established for M.In one aspect, the amount by which a delta value exceeds a thresholdestablished for (M−1) is less than the amount by which a delta valueexceeds a threshold established for M.

In an aspect, a level M intervention is chosen in accordance with [0063]to [0072], replacing N with M.

In one aspect, the present disclosure further provides for, andincludes, determining whether the second delta value is less than athird threshold, administering a level-(N−1) intervention if the seconddelta value is less than the third threshold and if the firstintervention is not of level-0, and making a plurality of SEMmeasurements at a pre-determined frequency corresponding to level-(N−1)if the second delta value is less than the third threshold.

In an aspect, a third threshold may be about 0.3, 0.35, 0.4, 0.45, 0.5,0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3,1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7,2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1,4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5,5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9,7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one aspect, a third threshold mayrange from 0.1 to 8.0, such as from 0.1 to 1.0, from 1.1 to 2.0, from2.1 to 3.0, from 3.1 to 4.0, from 4.1 to 5.0, from 5.1 to 6.0, from 6.1to 7.0, from 7.1 to 8.0, from 0.1 to 7.5, from 0.5 to 8.0, from 1.0 to7.0, from 1.5 to 6.5, from 2.0 to 6.0, from 3.0 to 5.5, from 3.5 to 5.0,or from 4.0 to 4.5. In an aspect, a third threshold can be scaled by afactor or a multiple based on the values provided herein. In one aspect,a third threshold can be the same as a second threshold. In an aspect, athird threshold can be greater than a second threshold. In one aspect, athird threshold can be less than a second threshold. In one aspect, athird threshold can be the same as a first threshold. In an aspect, athird threshold can be greater than a first threshold. In one aspect, athird threshold can be less than a first threshold.

In an aspect, a second delta value can be 0.1-99.5% of the thirdthreshold, such as 0.1-1%, 0.1-5%, 1-5%, 5-15%, 10-20%, 15-25%, 20-30%,25-35%, 30-40%, 35-45%, 40-50%, 0.1-25%, 15-35%, 25-50%, 25-75%, 45-55%,50-60%, 55-65%, 60-70%, 65-75%, 40-55%, 50-75%, 50-99.5%, 70-80%,75%-85%, 80-90%, 85-95%, 90-99.5%, 65-85%, or 75-99.5% of the thirdthreshold.

In one aspect, the present disclosure provides for, and includes, amethod of slowing the progression of pressure ulcer development in apatient in need thereof, the method comprising the steps of: identifyinga current intervention of level-K received by the patient, making aplurality of Sub-Epidermal Moisture (SEM) measurements in the patient,calculating a delta value from a portion of the plurality of SEMmeasurements, determining whether the delta value exceeds a firstthreshold, continuing to administer the current intervention if thedelta value does not exceed the first threshold, continuing to make aplurality of SEM measurements at a pre-determined frequencycorresponding to level-K if the delta value does not exceed the firstthreshold, administering a new intervention of level-N if the deltavalue exceeds the first threshold, where N has a value greater than K,and making a plurality of SEM measurements at a pre-determined frequencycorresponding to level-N if the delta value exceeds the first threshold.In an aspect, a patient in need thereof is a patient experiencing achange of care, a change in mobility, a change in nutrition, a change insensory perception, or a combination thereof. In one aspect, a patientin need thereof is a patient having developed an open ulcer. In anaspect, a patient in need thereof is a patient having recovered from anopen ulcer. In one aspect, a patient in need thereof is a patientreceiving surgery. In an aspect, a patient in need thereof is a patientreceiving spinal analgesics or sacral analgesics during a surgery. Inone aspect, a patient in need thereof is a patient receiving a surgeryfor a duration of four or more hours, such as five or more hours, six ormore hours, seven or more hours, eight or more hours, nine or morehours, ten or more hours, eleven or more hours, or twelve or more hours.In an aspect, a surgery has a duration of one or more hours, such as twoor more hours, or three or more hours.

In one aspect, a plurality of SEM measurements are taken in accordancewith [0057]. In an aspect, a delta value is determined in accordancewith [0058]. In one aspect, a first threshold is determined inaccordance with [0060].

In an aspect, K ranges from 2 to 50, such as from 2 to 3, from 2 to 4,from 2 to 5, from 2 to 6, from 2 to 7, from 2 to 8, from 2 to 9, from 2to 10, from 2 to 15, from 2 to 20, from 2 to 25, from 2 to 30, from 2 to35, from 2 to 40, or from 2 to 45.

In an aspect, K is determined by the amount by which the delta valueexceeds the threshold. In an aspect, the amount by which a delta valueexceeds a threshold established for (K+1) is greater than the amount bywhich a delta value exceeds a threshold established for K. In oneaspect, the amount by which a delta value exceeds a thresholdestablished for (K−1) is less than the amount by which a delta valueexceeds a threshold established for K.

In an aspect, a level K intervention is chosen in accordance with [0063]to [0072], replacing N with K.

In an aspect, the present disclosure further provides for, and includes,determining whether the delta value is less than a second threshold,administering a level-L intervention if the delta value is less than thesecond threshold, where L has a non-negative value less than K, andmaking a plurality of SEM measurements at a pre-determined frequencycorresponding to level-L if the delta value is less than the secondthreshold.

In an aspect, a second threshold is determined in accordance with[0080].

In an aspect, L can be K−1, K−2, K−3, K−4, K−5, K−6, K−7, K−8, K−9, orK−10. In one aspect, L is K−1 if a delta value is 90-99.5% of the secondthreshold, such as 90-95%, 91-96%, 92-97%, 93-98%, 94-99%, or 95-99.5%of the second threshold, unless K−1 is less than 0, in which case Lwould be 0. In an aspect, L is K−2 if a delta value is 80-89.9% of thesecond threshold, such as 80-85%, 81-86%, 82-87%, 83-88%, 84-89%, or85-89.9% of the second threshold, unless K−2 is less than 0, in whichcase L would be 0. In one aspect, L is K−3 if a delta value is 70-79.9%of the second threshold, such as 70-75%, 71-76%, 72-77%, 73-78%, 74-79%,or 75-79.9% of the second threshold, unless K−3 is less than 0, in whichcase L would be 0. In an aspect, L is K−4 if a delta value is 60-69.9%of the second threshold, such as 60-65%, 61-66%, 62-67%, 63-68%, 64-69%,or 65-69.9% of the second threshold, unless K−4 is less than 0, in whichcase L would be 0. In one aspect, L is K−5 if a delta value is 50-59.9%of the second threshold, such as 50-55%, 51-56%, 52-57%, 53-58%, 54-59%,or 55-59.9% of the second threshold, unless K−5 is less than 0, in whichcase L would be 0. In an aspect, L is K−6 if a delta value is 40-49.9%of the second threshold, such as 40-45%, 41-46%, 42-47%, 43-48%, 44-49%,or 45-49.9% of the second threshold, unless K−6 is less than 0, in whichcase L would be 0. In one aspect, L is K−7 if a delta value is 30-39.9%of the second threshold, such as 30-35%, 31-36%, 32-37%, 33-38%, 34-39%,or 35-39.9% of the second threshold, unless K−7 is less than 0, in whichcase L would be 0. In an aspect, L is K−8 if a delta value is 20-29.9%of the second threshold, such as 20-25%, 21-26%, 22-27%, 23-28%, 24-29%,or 25-29.9% of the second threshold, unless K−8 is less than 0, in whichcase L would be 0. In one aspect, L is K−9 if a delta value is 10-19.9%of the second threshold, such as 10-15%, 11-16%, 12-17%, 13-18%, 14-19%,or 15-19.9% of the second threshold, unless K−9 is less than 0, in whichcase L would be 0. In an aspect, L is K−10 if a delta value is 0.1-9.9%of the second threshold, such as 0.1-5%, 1-6%, 2-7%, 3-8%, 4-9%, or5-9.9% of the second threshold, unless K−10 is less than 0, in whichcase L would be 0.

In an aspect, the present disclosure provides for, and includes, amethod of stratifying groups of patients in a care facility based onpressure ulcer risk, the method comprising the steps of: making aplurality of Sub-Epidermal Moisture (SEM) measurements in each of thepatients, calculating a delta value from a portion of the plurality ofSEM measurements for each of the patients, determining whether eachdelta value exceeds any values in a set of threshold valuescorresponding to N care levels and assigning a care level to each of thepatients, rearranging the group of patients based on each of thepatient's assigned care levels.

In one aspect, the present disclosure provides for, and includes, amethod of reducing incidence of pressure ulcer in patients admitted to acare facility, the method comprising the steps of: evaluating a patientfor a risk of pressure ulcer upon admission to the care facility, wherethe evaluating step comprises making a first plurality of Sub-EpidermalMoisture (SEM) measurements in the patient, calculating a first deltavalue from a portion of the first plurality of SEM measurements,determining whether the first delta value exceeds a first threshold,administering a first intervention of level-0 if the first delta valuedoes not exceed the first threshold, and administering a firstintervention of level-N if the first delta value exceeds the firstthreshold, where N is an integer and N has a value of 1 or greater. Inan aspect, the incidence of ulcers in patients in the care facility isreduced to less than 1 in 100, less than 1 in 200, less than 1 in 300,less than 1 in 400, less than 1 in 500, less than 1 in 600, less than 1in 700, less than 1 in 800, less than 1 in 900, or less than 1 in 1000.

In an aspect, the present disclosure provides for, and includes, amethod of identifying and treating a patient in need of application of abarrier cream to the patient's heel, the method comprising the steps of:making a plurality of Sub-Epidermal Moisture (SEM) measurements at thepatient's heel, calculating a delta value from a portion of theplurality of SEM measurements, determining whether the delta valueexceeds a threshold corresponding to level N, where N is greater than orequal to 2, administering a barrier cream to the patient's heel if thedelta value exceeds the threshold, and making a plurality of SEMmeasurements every two hours if the delta value exceeds the threshold.In an aspect, a plurality of SEM measurements are made at least onceevery hour or at least once every half an hour if the delta valueexceeds the threshold.

In one aspect, the present disclosure provides for, and includes, amethod of identifying and treating a patient in need of application of aneuro-muscular stimulation to the patient's heel, the method comprisingthe steps of: making a plurality of Sub-Epidermal Moisture (SEM)measurements at the patient's heel, calculating a delta value from aportion of the plurality of SEM measurements, determining whether thedelta value exceeds a threshold corresponding to level N, where N isgreater than or equal to 2, administering a neuro-muscular stimulationto the patient's heel if the delta value exceeds the threshold, andmaking a plurality of SEM measurements every hour if the delta valueexceeds the threshold. In an aspect, a plurality of SEM measurements aremade at least once every half an hour if the delta value exceeds thethreshold.

In an aspect, the present disclosure provides for, and includes, amethod of identifying and treating a patient in need of application of atopical cream to the patient's heel, the method comprising the steps of:making a plurality of Sub-Epidermal Moisture (SEM) measurements at thepatient's heel, calculating a delta value from a portion of theplurality of SEM measurements, determining whether the delta valueexceeds a threshold corresponding to level N, where N is greater than orequal to 2, administering a topical cream to the patient's heel if thedelta value exceeds the threshold, and making a plurality of SEMmeasurements every half an hour if the delta value exceeds thethreshold.

In one aspect, the present disclosure provides for, and includes, amethod of identifying and treating a patient in need of application of abarrier cream to the patient's sacrum, the method comprising the stepsof: making a plurality of Sub-Epidermal Moisture (SEM) measurements atthe patient's sacrum, calculating a delta value from a portion of theplurality of SEM measurements, determining whether the delta valueexceeds a threshold corresponding to level N, where N is greater than orequal to 2, administering a barrier cream to the patient's sacrum if thedelta value exceeds the threshold, and making a plurality of SEMmeasurements every six hours if the delta value exceeds the threshold.In an aspect, a plurality of SEM measurements are made at least onceevery four hours, at least once every three hours, at least once everytwo hours, at least once an hour, or at least once every half an hour ifthe delta value exceeds the threshold.

In an aspect, the present disclosure provides for, and includes, amethod of identifying and treating a patient in need of application of aneuro-muscular stimulation to the patient's sacrum, the methodcomprising the steps of: making a plurality of Sub-Epidermal Moisture(SEM) measurements at the patient's sacrum, calculating a delta valuefrom a portion of the plurality of SEM measurements, determining whetherthe delta value exceeds a threshold corresponding to level N, where N isgreater than or equal to 2, administering a neuro-muscular stimulationto the patient's sacrum if the delta value exceeds the threshold, andmaking a plurality of SEM measurements every four hours if the deltavalue exceeds the threshold. In an aspect, a plurality of SEMmeasurements are made at least once every three hours, at least onceevery two hours, at least once an hour, or at least once every half anhour if the delta value exceeds the threshold.

In one aspect, the present disclosure provides for, and includes, amethod of identifying and treating a patient in need of application of atopical cream to the patient's sacrum, the method comprising the stepsof: making a plurality of Sub-Epidermal Moisture (SEM) measurements atthe patient's sacrum, calculating a delta value from a portion of theplurality of SEM measurements, determining whether the delta valueexceeds a threshold corresponding to level N, where N is greater than orequal to 2, administering a topical cream to the patient's sacrum if thedelta value exceeds the threshold, and making a plurality of SEMmeasurements every two hours if the delta value exceeds the threshold.In an aspect, a plurality of SEM measurements are made at least once anhour or at least once every half an hour if the delta value exceeds thethreshold.

In an aspect, methods of the present disclosure are performed using thedevices disclosed in U.S. application Ser. Nos. 14/827,375 and15/134,110. In one aspect, the moisture content is equivalent to the SEMvalue on a predetermined scale. In an aspect, a predetermined scale mayrange from 0 to 20, such as from 0 to 1, from 0 to 2, from 0 to 3, from0 to 4, from 0 to 5, from 0 to 6, from 0 to 7, from 0 to 8, from 0 to 9,from 0 to 10, from 0 to 11, from 0 to 12, from 0 to 13, from 0 to 14,from 0 to 15, from 0 to 16, from 0 to 17, from 0 to 18, from 0 to 19. Inone aspect, a predetermined scale can be scaled by a factor or amultiple based on the values provided herein.

In an aspect, the present disclosure further provides for, and includes,providing targeted treatment to an anatomical location of a patientidentified as being damaged by a combination of a visual assessment andSEM scan measurements. In one aspect, a targeted treatment is providedto a common site for pressure ulcers selected from the group consistingof: toes, heels, a sacrum, a spine, an elbows, shoulder blades, occiput,and ischial tuberosity. In an aspect, a targeted treatment isconcurrently provided to a second common site for pressure ulcersselected from the group consisting of: toes, heels, a sacrum, a spine,an elbows, shoulder blades, occiput, and ischial tuberosity. In oneaspect, a first site receiving a targeted treatment is known to cause adevelopment of pressure ulcer at a second site.

The present disclosure is illustrated by the following examples. Theexamples set out herein illustrate several aspects of the presentdisclosure but should not be construed as limiting the scope of thepresent disclosure in any manner.

EXAMPLES Example 1: Intervention Levels for Treating Pressure Ulcers inthe Heel

Subjects identified as being at risk for pressure ulcers in the heelwere treated in accordance with the following scheme:

TABLE 1 EXAMPLE INTERVENTION SCHEME FOR TREATING PRESSURE ULCER IN THEHEEL Frequency of Subsequent Corresponding Risk SEM Measurement SEMdelta Level Intervention Monitoring Ranges 0 provide good nutrition,standard every 24 hours SEM delta ≤ mattress, and/or turn every 24 hoursthreshold 1 provide a heel boot every 10 hours threshold < SEM delta ≤105% threshold 2 change of support surface at the beginning of each 105%threshold < nursing shift SEM delta ≤ 110% threshold 3 apply dressing toback or sides of every 12 hours 110% threshold < heel SEM delta ≤ 115%threshold 4 change to low-friction sheet cover every 8 hours 115%threshold < SEM delta ≤ 120% threshold 5 provide a low-friction paddedevery 6 hours 120% threshold < mattress surface for lower leg SEM delta≤ 125% threshold 6 turn patient at a shorter interval every 4 hours 125%threshold < SEM delta ≤ 130% threshold 7 apply barrier cream every 2hours 130% threshold < SEM delta ≤ 135% threshold 8 apply neuro-muscularstimulation every 1 hour 135% threshold < SEM delta ≤ 145% threshold 9apply topical cream to enhance every 30 minutes 145% threshold <perfusion SEM delta ≤ 150% threshold 10 provide silicone pad for lowerleg every 15 minutes 150% threshold < SEM delta

Example 2: Intervention Levels for Treating Pressure Ulcers in theSacrum

Subjects identified as being at risk for pressure ulcers in the sacrumwere treated in accordance with the following scheme:

TABLE 2 EXAMPLE INTERVENTION SCHEME FOR TREATING PRESSURE ULCER IN THESACRUM Frequency of Subsequent Corresponding Risk SEM Measurement SEMdelta Level Intervention Monitoring Ranges 0 provide good nutrition,standard every 24 hours SEM delta ≤ mattress, and/or turn every 24 hoursthreshold 1 reposition patient with wedge and/or every 10 hoursthreshold < keep sacrum dry SEM delta ≤ 110% threshold 2 change mattressto pressure- at the beginning of each 110% threshold < alleviatingmattresses nursing shift SEM delta ≤ 120% threshold 3 apply dressingover sacrum every 12 hours 120% threshold < SEM delta ≤ 130% threshold 4change to dynamic mattress every 8 hours 130% threshold < SEM delta ≤140% threshold 5 apply barrier cream every 6 hours 140% threshold < SEMdelta ≤ 150% threshold 6 apply neuro-muscular stimulation every 4 hours150% threshold < SEM delta ≤ 160% threshold 7 apply topical cream toenhance every 2 hours 160% threshold < perfusion SEM delta ≤ 170%threshold 8 provide silicone pad under the every 1 hour 170% threshold <patient's body SEM delta ≤ 180% threshold

Example 3: Identifying a Patient in Need of a Level-0 Intervention atSacrum

A patient was subjected to multiple SEM measurements at and around theboney prominence of the sacrum using an apparatus capable of measuringSEM measurements. Prior to performing the measurements, surface moistureand matter above the patient's skin surface were removed. An electrodeof the apparatus was applied to the patient's skin with sufficientpressure to ensure complete contact for approximately one second toobtain each SEM measurement.

SEM measurements were taken on a straight line across the sacrum of apatient. Multiple measurements were taken at a given measurementlocation. FIG. 2A is a sample visual assessment of healthy tissue. FIG.2B is a corresponding plot of the averages of SEM measurements taken ateach location. A threshold of 0.5 was chosen. A delta value wascalculated as the difference between the maximum average SEM value andthe minimum average SEM value, which was determined to be less than 0.5.Because the SEM delta value was below the threshold value, the patientwas identified to be in need of a level-0 intervention. Accordingly, thepatient was placed on a standard mattress, and was turned every 24hours.

Additional SEM measurements were taken every 24 hours until discharge.There was no change in the intervention level.

Example 4: Identifying a Patient in Need of a Level-n Intervention atSacrum

A patient was subjected to multiple SEM measurements taken on a straightline across the sacrum in accordance with the same procedure asdescribed in Example 3.

FIG. 3A is a sample visual assessment of damaged tissue. FIG. 3B is acorresponding plot of the averages of SEM measurements taken at eachlocation. A threshold of 0.5 was chosen. A delta value was calculated asthe difference between the maximum average SEM value and the minimumaverage SEM value, which was determined to be above 0.5. Because the SEMdelta value was more than 200% over the threshold value, the patient wasidentified to be in need of a level-8 intervention. Accordingly, thepatient was placed on a silicone pad and monitored on an hourly basisuntil a SEM delta value of less than 170% of the threshold value wasobserved, at which point, the patient was switched to a level-7intervention.

Example 5: Example Process for Selecting a Level of Intervention andMonitoring

FIG. 4 is an illustration of a process 400 for selecting a level ofintervention and monitoring based on the amount by which a delta valuederived from SEM measurements exceeds a threshold value. Here, acaregiver took a plurality of SEM measurements at a location on the skinof a patient using a SEM Scanner in step 402, where each measurementgenerated a SEM value. Using a portion of these SEM values, a deltavalue “a” was calculated in step 404. The delta value was calculated bysubtracting the smallest SEM value from the largest SEM value generatedfrom the plurality of SEM measurements.

The calculated delta value was compared to a threshold value “T” in step406. If the delta value was less than or equal to the threshold value,step 408 was executed and the caregiver waited until the monitoringinterval associated with the current level of care transpires, thenrepeated the SEM measurements in step 402. If the delta value wasgreater than the threshold value, the amount by which the delta valueexceeded the threshold value was compared to a cascading series ofdifference values.

In some instances, the delta value was positive and the comparisonexecuted by subtracting the threshold value from the delta value, whichproduced a positive difference, and then a determination was maderegarding whether the difference exceeded the first difference D1 instep 410. If the difference was less than D1, the process branched tostep 412 and then step 414 to implement an intervention and measurementinterval, respectively, associated with level-N+1. In this example, Nhad a value of zero or greater.

In some instances, the delta value was negative, for example if the SEMmeasurement at the center position of the data in FIG. 3B is subtractedfrom an average of the SEM values from the leftmost and rightmostlocations in FIG. 3B. In that case, the differences D1, D2 through Dnwas selected to have negative values that could have different absolutevalues than the corresponding difference values D1, D2 through Dn usedfor a positive delta value. Alternatively, the comparisons in steps 410,420, and 430 were changed to “≤” in place of the “≥” shown in FIG. 4.

Example 6: Workflow Guidance Matrix

FIG. 5 is an example of a workflow guidance matrix 500 where the currentlevel of intervention 502 and the new delta value 504 are used to selectthe new level of intervention 506. Here, a caregiver monitored thecondition of a patient by periodically taking a plurality of SEMmeasurements at one or more locations on the patient's skin. At the timeof these measurements, the patient received care associated with a levelof intervention and monitoring. In this example, level-0 (zero) wasassociated with a patient who was not considered to be at significantrisk for development of a pressure ulcer. Higher levels of interventionand monitoring were identified with the gradations of interventionranked, for example, according to cost, difficulty to implement, orother parameter identified by the care facility. When a caregiver wasmaking a new set of SEM measurements, they consulted this matrix byidentifying the row of the current level of intervention 502, the deltavalue determined from the latest set of SEM measurements 504, andidentified the level of intervention in the cell 506 at the intersectionof the row 502 and column 504. The caregiver could consider theidentified level of intervention as well as the current level ofintervention and the value of the delta in selecting a level ofintervention for the next time period.

In some instances, the values of the new levels of intervention in thecells 506 were similar from row to row. In some instances, the values ofthe new levels of intervention in adjacent cells 506 differed by asingle level or by more than one level. In some instances, the values ofthe new levels of intervention in adjacent cells 506 were the same inadjacent cells.

Example 7: Progression of Tissue Condition Leading to Pressure Ulcer

FIGS. 6A, 6B, and 6C depict an illustrative non-limiting example of aprogression over time of the tissue condition leading to a pressureulcer. FIG. 6A depicts a cross-section of healthy tissue 600, includingthe stratum corneum 602 and healthy cells 604 in the epidermis/dermis.The center electrode 606 and the toroidal electrode 608 of a SEM scannerare shown in cross-section in contact with the stratum corneum 602. Anillustrative indication of the sensitive region of the SEM Scanner isshown as the oval region 610. The region 610 has a depth of sensitivity.In some instances, the depth of sensitivity is in the range of 0.14 0.16inches. In some instances, the depth of sensitivity is less than 0.16inches.

FIG. 6B is an illustrative cross-section of slightly damaged tissue 620.Cellular damage, for example resulting from long-term application oflow-level pressure has affected the tissue. Without being limited bytheory, some of the cells 622 have ruptured, releasing the fluidcontents into an intercellular space 624. Alternatively, and withoutbeing limited by theory, an inflammatory reaction has caused fluid tomigrate into the intercellular space 624. This damage is not visible onthe skin surface.

FIG. 6C is an illustrative cross-section 640 of a more advanced level ofdamage. Without being limited by theory, the tissue is now mostlyruptured cells 622, which can provide little mechanical structure tocarry the continued applied pressure. The tissue thickness is reduced,with the bone 642 now closer to the skin surface. The ruptured cells 622and intercellular space 624 are compressed, expelling the fluid 644 outof the local tissue as indicated by arrows 646.

FIG. 6D shows an illustrative plot 660 of a delta value for a singlepatient at a single location where a pressure ulcer develops. The SEMvalues were measured by a SEM scanner. A delta value was generated fromsets of SEM measurements taken at incremental times. Point 672 was ameasurement at time=zero where all the SEM values had a baseline valueassociated with healthy tissue and the delta value is zero. At time t1,another set of SEM measurements was made and the associated delta valuewas indicated at point 674. This delta value was below the threshold 662and, therefore, there was no indication of significant sub-surfacedamage.

At time t2, the damage progressed and the delta value 676 was greaterthan the threshold 662, indicating that there was significant damage.This damage was still not visible on the skin. Nonetheless, a deltavalue greater than the threshold 662 indicated that there was cellulardamage at a depth less than the sensitive depth of the SEM scanner.

At time t3, the damage continued but the amount of fluid in theintercellular space was decreased due to mechanical expulsion asillustrated in FIG. 6C. This reduced the SEM value taken over thedamaged area, which reduced the computed delta value 678 since the SEMvalue of the healthy tissue remained much the same as during previousmeasurements.

At time t4, the damage progressed to the point where it was visible onthe skin surface, as shown in FIG. 3A. In some instances, time t4 mayoccur before one or both of t2 and t3. In some instances, time t4 mayoccur after the delta value has reached zero again along curve 670 aftertime t3 and before t5. Arrow 665 indicates that after time t4, thedamage remained visible. In some instances, the tissue may be consideredto be a “stage 1” pressure ulcer after time t4.

At time t5, the damage progressed to the point where sufficient fluidhad been expelled from the local tissue that the SEM value of ameasurement made over the damaged area was lower than the SEM value ofhealthy tissue. This resulted in the delta value 680 being negative, asshown in FIG. 3B. In some instances, the negative delta would indicatethat the tissue is seriously damaged. In some instances, the negativedelta would indicate that a portion of the tissue at the location of thelowest SEM value is necrotic.

Example 8: Method of Mapping an Area of Possible Damage I

FIG. 7A is an example of a method of mapping an area of possible damage.The area of damage 700 was surrounded by healthy tissue 708. The centerarea 730 was significantly damaged. The first surrounding area 720 wasless damaged, and the second surrounding area 710 was less damaged butstill not healthy tissue. The skin over all of these areas had the sameappearance and texture, with no indication of the subsurface damage. Theseries of dashed-line circles 740, 742, 744, 746, 748, and 750 indicatean example set of location where SEM measurements were taken. SEMmeasurements taken at locations 740, 742, and 750 generally produced aSEM value associated with healthy tissue, identified within this exampleas “H.” SEM measurements taken at locations 744 and 748 generallyproduced a SEM value “J” that is slightly higher than H. A SEMmeasurement taken at location 746 generally produced a SEM value “P”that is greater than J. All of these measurements were considered to betaken at a single “location” on the patient's body, for example thesacrum, even though the individual locations were spatially dispersedover this location. For this set of SEM values, the delta was thedifference between the highest SEM value, which likely occurred atlocation 746, and the lowest SEM value, which likely occurred at one oflocations 740, 742, and 750, within this set. If the delta was greaterthan a threshold value “T,” this was an indication that there issignificant damage at this location. The exact location of the greatestdamage was likely to be proximate to the measurement location 746 wherethe greatest SEM value was produced.

Example 9: Method of Mapping an Area of Possible Damage II

FIG. 7B depicts a second example of mapping an area of possible damage.In this example, the approximate location of the greatest damage wasknown, for example from prior application of the method illustrated inFIG. 7A. The intent of this method was to map the boundary between area710 and area 720 to determine the extent of the damage. For simplicity,the SEM values produced by measurements in each area were the same andthe SEM values increased from area 710 to area 720 and then to area 730.The first SEM measurement was taken at location 760, which was known tobe the approximate location of the greatest damage. Subsequentmeasurements were taken at locations 762, 764, 766, and 768 in the orderindicated by path 780. The SEM value produced at location 764 wasslightly higher than the SEM values produced at locations 762 and 766,indicating that location 764 was partially within the area 720 whilelocations 762 and 766 were fully within the lesser-damaged area 710. Theboundary could be approximated by interpolating between the variousmeasurement locations. For example, the SEM value produced at location770 was high enough to suggest that it is fully within the area 720 andtherefore did not help identify the boundary between areas 710 and 720.The subsequent location 772 was therefore directly away from thestarting location 760. As location 760, in this example, was now fullywithin area 710, the boundary between areas 710 and 720 could beinterpolated to be between locations 770 and 772. The SEM value producedfrom a measurement at location 774 was similar to the SEM value fromlocation 770 and it could be sufficient to identify the boundary asoutside the location 774 without taking another measurement at alocation corresponding to location 772.

This set of measurements enabled the creation of a map of a certainlevel of damage, for example the area 720. Repeating this mappingprocess at regular time intervals would provide an indication of whetherthe area 720 is growing, which may indicate that an increased level ofintervention is appropriate, or shrinking, which may indicate that thecurrent level of intervention is allowing the damage to heal.

Example 10: Treatment Decision Pathway for Stratifying Patients andProviding Appropriate Treatments

FIG. 8A outlines a currently recommended treatment decision pathway forpreventing pressure ulcers in hospital patients as presented by TheNational Institute for Health and Care Excellence (NICE) in theirclinical guideline Pressure ulcers: prevention and management, published23 Apr. 2014. The guidelines recommend that a risk analysis be performedfor every patient admitted to a care facility that exhibits one or morerisk factors such as significantly limited mobility, a significant lossof sensation, a previous or current pressure ulcer, a nutritionaldeficiency, an inability to reposition themselves, or a significantcognitive impairment. Risk assessment is commonly done using a scoredchecklist, such as the Braden Scale, that assesses the severity ofspecific risk factors.

Upon completion of the risk assessment, the patient is identified as (i)having a low risk of developing a pressure ulcer, (ii) being at risk ofdeveloping a pressure ulcer, or (iii) being at high risk of developing apressure ulcer. Depending on the level of risk the patient is classifiedas having, the patient undergoes different sequences of treatment andevaluation by visual assessment.

All patients are potentially at risk of developing a pressure ulcer.They are more likely to occur in people who are seriously ill or have aneurological condition, impaired mobility, impaired nutrition, poorposture, or a deformity.

Pressure ulcers are categorized as stage-1 through stage-4, with stage-1being the lowest condition. The National Pressure Ulcer Advisory Panel(NPUAP) has defined a “stage-1” ulcer as intact skin with a localizedarea of non-blanchable erythema, where “blanchable” indicates that thetissue loses all redness when pressed and “non-blanchable” tissueremains red when pressed due to the presence of red blood cells outsideof blood vessels (extravasation). In some patients, blanchable erythemaor changes in sensation, temperature, or firmness may precede visualchanges.

Visual skin assessment (VSA) is the current method of identifying apressure ulcer. A trained healthcare professional assesses theappearance of the skin, visually and tactilely, looking for redness orvariations in tissue firmness, tissue temperature, or moisture.

If a patient is identified as having a low risk of developing a pressureulcer, the patient is simply monitored for a change in clinical statussuch as undergoing surgery, worsening of an underlying condition, or achange in mobility. A patient who uses a wheelchair or sits forprolonged periods may be provided with a high-specification foam cushionor equivalent pressure-distributing cushion. If there is no change inclinical status, a low-risk patient will not be reassessed under thisset of guidelines and stays within the same treatment and evaluationpathway until he or she is discharged from the care facility.

If a patient is identified as being at risk of developing a pressureulcer, the patient will be scheduled to be turned, or “rounded,” every 6hours. As with the low-risk patient, a high-spec foam cushion may beprovided if the patient uses a wheelchair or sits for prolonged periodsof time. No other monitoring or intervention is recommended by the NICEguidelines.

A high-risk patient receives a high-spec foam mattress as a preventativemeasure, provided with a high-spec cushion if they are in a wheelchairor sit for prolonged periods of time, and will be turned every 4 hours.The patient will receive a daily VSA for all areas of the body. If anarea is found to have non-blanchable erythema, an appropriateintervention will be implemented and that area re-checked by VSA every 2hours. Areas that do not exhibit non-blanchable erythema are re-checkeddaily by VSA. A personalized care plan will be developed for eachhigh-risk patient.

It can be seen from this flow chart that the majority of the time spentby caregivers will be on the high-risk patients. While this may beappropriate, it leaves the at-risk patients unmonitored and they maydevelop a stage-1 ulcer before the condition is observed by a caregiver.Furthermore, the consequence of relying on VSA to detect a problemnecessarily means that patients will develop a stage-1 ulcer before anintervention is selected or implemented. By the time that the damage hasprogressed to stage-1, it is likely that the skin will break and becomea stage-2 ulcer despite intervention. There is a clear need to identifytissue damage earlier so that interventions can prevent progression ofthe subepidermal damage to stage-1 and beyond.

FIG. 8B is an example of a current augmented treatment decision pathwayfor preventing pressure ulcers as currently implemented at some healthcare facilities. The augmented pathway adds monitoring steps to both theat-risk and the low-risk paths. A low-risk patient received a weeklyrisk assessment, for example completion of the Braden Scale assessment.A patient identified as at-risk in the initial assessment will receive ahigh-spec foam mattress as a preventative measure and will be evaluateddaily by VSA. A care plan will be developed for the monitoring andtreatment of the at-risk patient. No change is made in the care if ahigh-risk patient.

The augmented plan has the benefit of providing basic monitoring of allpatients for pressure ulcers. The additional steps require additionaltime, however, either by adding staff or further burdening the existingstaff. While superior to the recommended care pathway of FIG. 8A, thecare pathway of FIG. 8B requires more resources and still suffers fromthe limitation that a patient must develop a stage-1 ulcer before VSAidentifies the damage.

Various hospitals and care facilities use different numbers of riskcategories, ranging from two categories, low-risk and at-risk, to fouror more categories, adding categories such as “very-high-risk” to thecategories of the example of FIG. 8B. Patients are assigned to thevarious categories based on the results of the initial risk assessment.

FIG. 9 is an example flowchart of how a SEM Scanner may be used in astand-alone process to prevent pressure ulcers, in accordance with thepresent disclosure. Every incoming patient receives a complete SEMscanner assessment of all body locations that are selected formonitoring. These selected locations may include areas recommended inthe Instructions For Use (IFU) of the SEM scanner, such as the sacrumand the heels. Additional locations may be identified by the hospitaland integrated into their in-house practice. Multiple SEM measurementsare taken at and around each body location at positions that areseparated from each other, although this is generally referred to astaking multiple measurements at the body location. The SEM scannercalculates a “delta” value for each location from the set ofmeasurements taken at and around that location. The delta value is thencompared to one or more threshold values to categorize a patient. Inthis example, the patient is assigned to one of two risk categories:low-risk and at-risk.

In an aspect, the clinician will perform an SEM scan of a body locationidentified as having possible damage in the initial SEM scan at a firsttime interval. The clinician will also perform an SEM scan of all otherbody locations selected for monitoring at a second time interval that islonger than the first time interval. In an aspect, the values of thefirst and second time intervals are different depending on the riskcategory to which the patient has been assigned. For example, ahigh-risk patient will have a first time interval of 4 hours and asecond time interval of 1 day while an at-risk patient will have a firsttime interval of 1 day and a second time interval of 1 week. In anaspect, the time interval may be event-based, for example upon a changeof attending staff or shift change, rather than strictly based on time.In general, body locations that have elevated delta values are scannedmore often than other body locations that are monitored but havingnormal delta values in previous SEM scans.

In an aspect, the interval at which an SEM scan is performed isdetermined by the delta values from the prior SEM scan. For example, anSEM scan of a body location that had a delta value greater than or equalto a first threshold in a previous SEM scan is performed at a first timeinterval, while an SEM scan is performed at a second time interval thatis shorter than the first time interval when the prior SEM scan of abody location had a delta value greater than or equal to a secondthreshold that is higher than the first threshold.

In this example, low-risk patients receive a weekly SEM scan of all bodylocations that are selected for monitoring. This is a small effort thatprovides basic protection for even the healthiest patients, as a weeklySEM scan is likely to detect tissue damage before it becomes visible toVSA.

At-risk patients, which will include patients that would be identifiedas high-risk in the current care pathways of FIGS. 8A and 8B, willreceive specialized care based on the body location that exhibits adelta value above a threshold. For example, if the sacrum body locationhas a delta value above a threshold, the patient will be repositionedevery 6 hours and receive a SEM scan of the sacrum every day and an SEMscan of the other body locations every week.

FIG. 10 is an example flowchart of how a SEM Scanner may be used as anadjunct to further improve the augmented treatment decision pathway ofFIG. 8B, in accordance with the present disclosure. An incoming patientreceives both a risk assessment and an SEM scan of all body locationsidentified by the hospital for monitoring and the assignment of apatient to a risk category is based partially on the risk assessment andpartially on the SEM scan results. An initial delta value that isgreater than a threshold is an indication that there is possible damageat that body location. In an aspect, the assignment is based solely onthe largest initial delta value found during the initial SEM scan.

A decision whether to implement an intervention, for example turning thepatient at a first interval, is currently based on the VSA and riskassessment despite the uncertainty of whether there is early stagedamage below the skin. In an aspect, the decision to implement anintervention for a particular body site, or a general intervention suchas a high-spec mattress, is based on the delta value found for that sitein the SEM scan. If the delta value is less than a predeterminedthreshold, no intervention is required. If the delta value is greaterthan the predetermined threshold, then an intervention is selected andimplemented based partially on the body location and partially on thedelta value for that body location. The predetermined threshold forwhether or not to select and implement an intervention may be higher orlower than the threshold for determination that there is possible damageat the body location.

A comparison of the costs of provided the care pathways of FIGS. 8A, 8B,9, and 10 reveals one of the benefits of utilizing the SEM scanner tomonitor patients. Note that the costs cited herein are for patients whodo not have or develop pressure ulcers, in which case the estimatedtreatment cost jumps to $2000 for a stage-1 ulcer.

The baseline for this comparison is the augmented current practice ofFIG. 8B, which represents a current “best practice” for hospitalsstriving to reduce the incidence rate of pressure ulcers. Providing thecare of the low-risk care pathway is expected to cost an average of $26per patient for the average hospital stay of 5.6 days, the care for anat-risk patient is estimated to cost an average of $121, and a high-riskpatient is expected to cost $165. All of the care pathways rely on a VSAto detect a pressure ulcer and are otherwise implementing interventionsbased on “typical” patient progression rather than the particularpatient's condition.

Integrating the SEM scanner into the current “best practice” workflow,as shown in FIG. 10, does not lower the cost of any of the care pathwaysas no work element is being eliminated. The benefit is in the ability todetect tissue damage at an earlier stage at a minimal incremental cost.The incremental cost of adding a SEM scan to the no-risk care pathway is$2, raising the cost from approximately $26 to $28. The expected cost ofcaring for an at-risk patient who does not have an elevated SEM scandelta value, i.e. does not have subepidermal tissue damage, is alsoincreased by only $2. If an at-risk patient is found to have an elevatedSEM scan delta value, however, the patient is escalated to the high-riskcategory, where the expected cost of care increases from $165 to $169.While this may seem like an additional cost at first glance, itrepresents an increase in the level of protection provided to at-riskpatients.

FIG. 9 represents an example workflow that relies solely on an SEMscanner to monitor patients and forgoes the routine VSA. The expectedcost of preventative care for a low-risk patient is $4, compared to the$28 cost for the integrated low-risk care pathway of FIG. 10. For anat-risk patient, which is the only other category for the SEM scannercare pathway of FIG. 9, the expected cost is $97, compared to the$123-$169 costs for the at-risk and high-risk patients of the integratedcare pathway of FIG. 10.

FIG. 11 illustrates the concept of providing a continuity of care acrossmultiple care settings, in accordance with the present disclosure. Thisexample shows a care pathway 1100 for a patient being sequentially caredfor in a plurality of care settings, starting from a home care setting1110. A decision is made to transfer the patient to a hospital 1150where the patient is initially admitted to a medical/surgical (med/surg)unit 1120. After receiving care in the med/surg unit 1120 for some time,the patient is transferred to a long-term care unit 1130 within the samehospital 1150. After further treatment, the patient is discharged fromthe hospital 1150 to a skilled nursing facility 1140. Although not shownin FIG. 11, care pathway 1100 is not limited to this sample sequence andcombination of care settings. For example, care pathway 1100 may alsoinvolve a discharge of a patient back to the home care setting.

In an aspect, a central “registry” or database 1160 is established toaggregate data from all care settings as well as the condition of thepatient at the time of transfer between care settings.

While in each care setting, for example the home care setting 1120,health information regarding the patient is recorded and transferred tothe database 1160 in a data record 1112. The health information mayinclude the results of examinations or tests, observations,measurements, treatments, the implementation of interventions that areintended to prevent the development of pressure ulcers, dietarynotations, and other records related to the condition and treatment ofthe patient. A data record from a care setting may include one or moreof a patient identifier, a data element from the group of nutritionalinformation, an implemented intervention, a risk assessment, a visualskin assessment, a care plan, a doctor's note, lean event, a vital sign,a “measure of health” such as skin redness or an indication of mobilityor a measure of cognition, a body weight, and a lab result, and adate/time associated with the data element. Data records may vary instructure and content. A data record reported to the database maycontain one of more of the following data elements:

-   -   a) a patient identifier    -   b) a transaction date    -   c) a facility identifier    -   d) a location of the transaction    -   e) nutritional information    -   f) an implemented intervention    -   g) a risk assessment    -   h) a visual skin assessment    -   i) a care plan    -   j) a doctor's note (diagnosis, order, prescription, request for        test, procedure, treatment, etc.)    -   k) results of a test, procedure, or treatment    -   l) an event    -   m) a vital sign    -   n) a body weight    -   o) a lab result

When a patient is transferred between care setting, for example from thehome care setting 1110 to the med/surg care setting 1120, a transferrecord 1114 is created and reported to the database 1160. Transferringinformation regarding risk and health information related to pressureulcers will improve the care provided in the new care setting. In anaspect, the transfer record 1114 comprises a patient assessmentperformed at the “from” care site after the decision to transfer thepatient has been made. In an aspect, the assessment comprises an SEMscan of at least one body location, wherein the SEM scan comprises aplurality of SEM values measured at a single body location andcalculation of a delta value from the plurality of SEM values. In anaspect, the transfer record contains a history of prior SEM valuesand/or delta values while in the “from” care setting. In an aspect, thetransfer record contains one or more of a VSA, a risk analysis, andother health data. A transfer record may contain one of more of thefollowing data elements:

a) a patient identifier

b) a transaction date/time (date and time, time zone or Greenwich MeanTime)

c) a transaction type (pre-admit, admit, transfer, discharge, etc.)

d) a “To” Location

e) a “From” Location

f) a facility/unit identifier

g) a risk assessment

h) a visual skin assessment

i) a photograph of a body location

A patient may move periodically from a primary care setting, for examplea home care setting 1110, to an advanced care setting, for example along-term acute care unit 1130, where the patient will undergo an“episode of care” by doctors or other skilled professionals. Datarecords of the assessments and care provided in the advanced caresetting are reported to the database 1160. Upon discharge from thelong-term acute care setting 1130 to the home setting 1110, data recordscontaining care instructions, prescriptions, and other guidance for carein the home setting 1110.

With data from the entire care pathway 1100 aggregated in the database1160, it is possible to query the database 1160 to retrieve the deltavalues observed over time for a particular patient across multiple caresettings and various episodes of care.

In an aspect, a query is structured to determine whether instructionsfrom monitoring and/or treatment of a patient are being followed.

In an aspect, a query is structured to determine whether a treatment ofa patient is effective.

In an aspect, a query is structured to determine whether an outcome of apatient is related to one or more of the data elements reported to thedatabase 1160.

In an aspect, a query is structured to retrieve one or more measures ofhealth along with delta values to evaluate possible linkages between theretrieved measures of health and the development of a pressure ulcer orother outcomes (development of other health con. The delta values areplotted against the date/time of measurement to form a time history ofthe delta values for a body location. In an aspect, the dealt values areanalyzed to determine one or more of a slope, an acceleration, a curveshape and associated characteristics, and a time-to-intercept of aselected threshold value. In an aspect, these analytical results can beused to implement the methods and processes of FIGS. 1 and 4.

From the foregoing, it will be appreciated that the present disclosurecan be embodied in various ways, which include but are not limited tothe following:

While the present disclosure has been described with reference toparticular aspects, it will be understood by those skilled in the artthat various changes may be made and equivalents may be substituted forelements thereof without departing from the scope of the disclosure. Inaddition, many modifications may be made to a particular situation ormaterial to the teachings of the disclosure without departing from thescope of the disclosure. Therefore, it is intended that the disclosurenot be limited to the particular aspects disclosed but that thedisclosure will include all aspects falling within the scope and spiritof the appended claims.

We claim:
 1. A method of providing a continuity of care for a patientduring transfer between care settings, the method comprising the stepsof: deciding to transfer a patient from a first care setting to a secondcare setting, performing a first assessment of the patient in the firstcare setting, preparing a transfer record of the assessment, andtransferring the transfer record with the patient to the second caresetting.
 2. The method of claim 1, wherein the first assessmentcomprises performing a sub-epidermal moisture (SEM) scan of at least onebody location of the patient.
 3. The method of claim 2, wherein the SEMscan comprises a plurality of measurements of an SEM value at the bodylocation and calculation of a delta value from the plurality of SEMvalues.
 4. The method of claim 3, further comprising the step of:performing a plurality of SEM scans of the patient at different timeswhile in the first care setting, and recording the delta values fromeach of the respective SEM scans, wherein the decision to transfer thepatient is based partially on the delta values recorded while in thefirst care setting.
 5. The method of claim 4, wherein the transferrecord comprises the delta values from a portion of the plurality of SEMscans of the patient taken at different times while in the first caresetting.
 6. The method of claim 2, wherein the SEM scan is performed atall body locations identified for monitoring.
 7. The method of claim 1,wherein the first assessment comprises at least one of a risk assessmentof the patient, a visual skin assessment of at least one body locationof the patient, and an image of the at least one body location.
 8. Themethod of claim 1, wherein the transfer record comprises at least one ofa transaction type, a transaction date/time, a “to” location, and a“from” location.
 9. The method of claim 1, further comprising the stepsof: performing a first SEM scan of at least one body location of thepatient while in the first care setting, wherein the first SEM scancomprises a plurality of measurements of an SEM value at the bodylocation and calculation of a first delta value from the plurality ofSEM values, creating a first data record that comprises the first deltavalue, reporting the first data record to a database, and reporting thetransfer record to the database.
 10. The method of claim 9, wherein: thefirst data record comprises a patient identifier and a first date/timewhen the first SEM scan was performed, and the transfer record comprisesthe patient identifier and a second date/time when the first assessmentwas performed.
 11. The method of claim 10, further comprising the stepsof: performing an SEM scan of the at least one body location of thepatient and calculating a second delta value while in the second caresetting, creating a second data record that comprises the patientidentifier, the second delta value, and a third date/time when thesecond SEM scan was performed, and reporting the second data record to adatabase.
 12. The method of claim 11, further comprising the step of:querying the database to retrieve a portion of data records thatcomprise the delta values of the at least one body location of thepatient.
 13. The method of claim 12, further comprising the step of:formatting the retrieved delta values in date/time order, and displayingthe formatted delta values.
 14. The method of claim 10, furthercomprising the steps of: creating an additional data record thatcomprises the patient identifier, a data element from the group ofnutritional information, an implemented intervention, a risk assessment,a visual skin assessment, a care plan, a doctor's note, lean event, avital sign, a body weight, and a lab result, and a date/time associatedwith the data element, and reporting the additional data record to thedatabase.
 15. The method of claim 13, wherein the formatted delta valuesis displayed in the form of a curve.
 16. The method of claim 15, furthercomprising the step of analyzing the retrieved delta values to determineone or more of a slope, an acceleration, a curve shape and associatedcharacteristics, and a time-to-intercept of a selected threshold value.17. The method of claim 16, wherein acceleration is determined by therate of change of the slope of the curve.
 18. The method of claim 16,wherein the decision to transfer the patient is based partially on oneor more of the slope, the acceleration, the curve shape and associatedcharacteristics, and the time-to-intercept of a selected thresholdvalue.
 19. The method of claim 11, further comprising the steps of:performing an SEM scan of the at least one body location of the patientand calculating a third delta value while in the third care setting,creating a third data record that comprises the patient identifier, thethird delta value, and a fourth date/time when the third SEM scan wasperformed, and reporting the third data record to a database.
 20. Themethod of claim 19, further comprising the step of querying the databaseto retrieve the delta values observed over time for a particular patientacross multiple care settings and various episodes of care.